Status:
COMPLETED
Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study
Lead Sponsor:
First Affiliated Hospital of Guangxi Medical University
Collaborating Sponsors:
Peking University People's Hospital
Ruijin Hospital
Conditions:
Thalassemia Major
Eligibility:
All Genders
2-20 years
Phase:
PHASE4
Brief Summary
The only curative therapy for thalassemia major remains the replacement of the defective erythropoiesis by allogeneic hematopoietic stem cell transplantation(allo-HSCT). We conduct a prospective multi...
Detailed Description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is one of the established curative option for thalassemia major (TM). Previous study has predicted that more than 90% of TM patients can ...
Eligibility Criteria
Inclusion
- Diagnosed with thalassemia major.
- Indication of hematopoietic stem cell transplantation.
- A cardiac ejection fraction of \>50%; normal pulmonary function tests and pulmonary examination results; and normal kidney function.
Exclusion
- Aspartate aminotransferase levels \> 4-fold the upper limit of the normal range for our institution's lab criteria;
- Uncontrolled bacterial, viral or fungal infections;
- Any other restriction for transplantation.
Key Trial Info
Start Date :
July 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
823 Patients enrolled
Trial Details
Trial ID
NCT04009525
Start Date
July 5 2019
End Date
October 31 2023
Last Update
August 9 2024
Active Locations (1)
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1
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 510515